JMS APHERESIS NEEDLE SET WINGEATER(R) V2


Device Classification Name

needle, fistula

510(k) Number K112178
Device Name JMS APHERESIS NEEDLE SET WINGEATER(R) V2
Applicant
JMS NORTH AMERICA CORPORATION
1468 harwell ave.
crofton, 
MD 
21114

Applicant Contact e.j. smith
Correspondent
JMS NORTH AMERICA CORPORATION
1468 harwell ave.
crofton, 
MD 
21114

Correspodent Contact e.j. smith
Regulation Number 876.5540
Classification Product Code
FIE  
Subsequent Product Code
FOZ  
Date Received 07/28/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No